Allergic rhinoconjunctivitis due to house mite dust allergy
Conditions
Interventions
Product Name: Microencapsulated house dust mite extract D.farinae
Product Code: MHDME D. farinae
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not available
CAS Number: N/A
Current Sponsor c
Sponsors
Curalogic A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 to 65 years old, both inclusive; - Have a history of perennial allergic rhinitis; - Have a positive skin prick test (SPT) to a standardized HDM (D. pteronyssinus and D. farinae) extract performed within the last six months before screening, which is defined as: • Diameter of the weal of at least the size of the positive control (histamine- dihydrochloride) and • Diameter of the weal of at least 3 mm for each of the HDM (D. pteronyssinus or D. farinae) species; - Have an allergen-specific IgE to HDM (D. pteronyssinus and D. farinae) with a concentration of at least 0.7 kU/L using the Phadia ImmunoCAP assay (Freiburg, Germany); the test should be performed within the last six months; - Have a positive reaction to a nasal challenge or to an eye challenge with HDM (D. pteronyssinus) extract; the test should be performed within the last six months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Have a severe autoimmune disease or a severe immunodeficiency; - Are currently receiving immunotherapy to any allergens or have received HDM immunotherapy within three years before the Screening Visit (immunotherapy to other allergens than HDM discontinued within 90 days before the Screening Visit is allowed); - Have moderate to severe persistent asthma (Global Initiative for Asthma, GINA, criteria III and IV); - Have insufficiently treated asthma and/or irreversible airway obstruction with a value of forced expiratory volume (FEV1) <70% of predicted (mean out of three acceptable values) despite of asthma medication - Use prohibited medications or have inadequate washout periods before the start of the study. The following medications are prohibited during the study and if taken before the study, the required wash-out periods are indicated in brackets: • Oral corticosteroids (one month); • Leukotriene (seven days); • Antihistamines: o H1-blocker (three days), • Anti-lgE medication (six months), • Tricyclic antidepressants (14 days); • Use of beta-receptor antagonists (oral, topical) before the study and need to use them during the study. - History of hypersensitivity to the IMP or its excipients (subjects enrolled in this study are expected to be allergic to HDM). Hypersensitivity to the IMP means that the subject has had a previous generalized or severe local reaction to HDM extract previously used for SPT or immunotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the maximal tolerated dose of MHDME in subjects allergic to house dust mite (HDM);Secondary Objective: To evaluate safety and tolerability of escalating doses of MHDME in subjects allergic to HDM;Primary end point(s): Adverse events, laboratory analyses, physical examination | — |
Countries
Germany
Outcome results
None listed